Thermal behavior of paracetamol-polymeric excipients mixtures

F. Giordano, A. Rossi, R. Bettini, A. Savioli, A. Gazzaniga, Cs Novák

Research output: Contribution to journalArticle

37 Citations (Scopus)

Abstract

The thermal behavior of binary mixtures of paracetamol and a polymeric excipient (microcrystalline cellulose, hydroxypropylmethylcellulose and cross-linked poly(vinylpyrrolidone)) was investigated. The physical mixtures, ranging from 50 to 90% by mass of drag, were submitted to a heating-cooling-heating program in the 35-180°C temperature range. Solid-state analysis was performed by means of differential scanning calorimetry (DSC), hot stage microscopy (HSM), micro-Fourier transformed infrared spectroscopy (MFTIR), and scanning electron microscopy (SEM). The polymeric excipients were found to address in a reproducible manner the recrystallization of molten paracetamol within the binary mixture into Form II or Form III. The degree of crystallinity of paracetamol in the binary mixtures, evaluated from fusion enthalpies during the first and second heating scans, was influenced by the composition of the mixture, the nature of the excipient and the thermal history. In particular, DSC on mixtures with cross-linked poly(vinylpyrrolidone) and hydroxypropylmethylcellulose with drug contents below 65 and 75%, respectively, evidenced the presence only of amorphous paracetamol after the cooling phase. Microcrystalline cellulose was very effective in directing the recrystallization of molten paracetamol as Form II.

Original languageEnglish
Pages (from-to)575-590
Number of pages16
JournalJournal of Thermal Analysis and Calorimetry
Volume68
Issue number2
DOIs
Publication statusPublished - Jun 20 2002

Keywords

  • DSC
  • Excipient
  • HSM
  • MFTIR
  • Paracetamol
  • Polymorphism
  • SEM

ASJC Scopus subject areas

  • Condensed Matter Physics
  • Physical and Theoretical Chemistry

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